MD-14 & MD-15 Import License

MD-14 application must be supported by a complete set of documents from both the foreign manufacturer and the Indian Authorised Agent or Importer. The mandatory documents required for the MD-14 application and grant of MD-15 license are listed below:

• Power of Attorney (POA) — duly notarised and apostilled
• Free Sale Certificate (FSC) from the country of origin
• ISO 13485 Certificate of the manufacturing site
• CE Certificates and Declaration of Conformity
• Plant Registration / Manufacturing Site Certificate
• Latest Inspection or Audit Report (not older than 3 years)
• Plant Master File (PMF) and Device Master File (DMF)
• Product Labels and Instructions for Use (IFU)
• Risk Analysis and Essential Principles Checklist
• Manufacturer's Authorisation Letter and Undertaking
• Wholesale License (Form MD-42 or Form 20B / 21B)
• Certificate of Incorporation and GST Registration
• Import-Export Code (IEC) and PAN
• Covering Letter, Importer Label, and Government Fee Challan

Fees for filing the MD-14 application and obtaining the MD-15 import license are prescribed under the Second Schedule of the Medical Device Rules, 2017. The fees are denominated in US Dollars and are payable in the equivalent Indian Rupee value through the CDSCO SUGAM portal. The applicable government fees are given below:

Government Fees for Non-IVD Medical Devices:

Government Fees for In-Vitro Diagnostic (IVD) Medical Devices:

Form MD-14 and MD-15 are closely interlinked under the Medical Device Rules, 2017. Form MD-14 is the form used by an applicant before the Central Licensing Authority to seek permission before importing a medical device in India. Whereas Form MD-15 is the actual import license issued by the CDSCO once the MD-14 application, supported by its complete technical and legal documents, is found in order.

MD-14 application form is submitted by an Authorized Indian Agent through the CDSCO SUGAM portal. The Application must be filed along with a complete document, including Plant Master File & Device Master File, apostilled Power of Attorney issued by the foreign manufacturer, Free Sale Certificate, ISO 13485 certification, relevant CE certifications, importer’s KYC documentation, and proof of payment of the prescribed government fee. Upon being satisfied with the application and supporting documents, the Central Licensing Authority issues Form MD-15 — the import license — in the name of the Authorized Indian Agent.

Note: Class A medical devices that are non-sterile and non-measuring are not required to obtain Form MD-15. Such devices fall under a simplified registration process prescribed under Rule 19A of the Medical Device Rules, 2017, which applies to low-risk basic devices.

Processing time for an MD-15 import license depends on the risk classification of the medical device, the completeness of the documents, and the responsiveness of the applicant during the CDSCO review process. The indicative timelines for the grant of the MD-15 license under the Medical Device Rules, 2017 are given below:

Indicative CDSCO Review Timelines (After Submission of MD-14)

Note: Class A and B applications generally take 3 to 5 months, while Class C and D applications take 6 to 9 months, based on the level of complexity of the medical device, documentation and requirement for overseas manufacturing site inspection by CDSCO.

Import of medical devices in India operates under an organized four-tier framework. The parent legislation is the Drugs and Cosmetics Act, 1940, which provides the overarching legal foundation. The detailed operational provisions are laid out in the Medical Device Rules, 2017, notified on January 31st, 2017, and brought into force from 1st January 2018. The Central Drugs Standard Control Organization (CDSCO) is regulatory authority responsible for the proper implementation of these rules. CDSCO functions under the Ministry of Health and Family Welfare and headed by the Drugs Controller General of India (DCGI). For all matters relating to medical device import licenses, the Central Licensing Authority (CLA) is the competent authority, irrespective of the risk class of the device.

Absence of a valid MD-15 license can disrupt the entire supply chain — from customs clearance to institutional sales and digital marketplace listings. The significance of holding a valid MD-15 license can be understood across the following key areas:

• Customs Clearance: Imported medical devices cannot be cleared at Indian ports without a valid MD-15 license. Consignments without proof of license are detained until the necessary regulatory documentation is produced.
• Hospital and Government Tenders: Both government and private health care organizations need a CDSCO import license number for participation in tenders. Listing in the Government e-Marketplace (GeM) is similarly conditional upon possession of an MD-15 license.
• E-Commerce and Marketplace Listings: Leading healthcare e-commerce platforms verify the MD-15 license status of sellers before onboarding them or approving product listings.
• Investor Due Diligence and Insurance Compliance: Investors, auditors, and insurance empanelment authorities routinely review CDSCO compliance status as part of due diligence and reimbursement eligibility checks.

MD-15 import license can be obtained only by entities that meet the eligibility conditions prescribed under the Medical Device Rules, 2017. The categories of applicants eligible to apply for the MD-14 / MD-15 license are as follows:

• Indian importer : An entity involved in the business of importing medical devices in India and holding a valid wholesale drug license either Form 20B & 21B as per Drugs and Cosmetics Rules, 1945, or Form MD-42 as per Medical Device Rules, 2017. This is the most common category of applicants and typically includes distributors authorized to represent foreign manufacturers in India.
• Indian manufacturer : A manufacturer holding a valid manufacturing license issued under the Medical Device Rules, 2017 — namely Form MD-3 or MD-5 (for Class A and Class B devices) or Form MD-7 or MD-9 (for Class C and Class D devices). This category applies to manufacturers who, in addition to producing devices in India, also import complementary or related product lines under the same business operations.
• Indian Subsidiary or Authorized Indian Agent: A wholly owned subsidiary, branch office, or duly appointed Authorized Indian Agent of a foreign manufacturer, having a registered office in India and holding a valid wholesale license to receive, store, and distribute the imported medical devices. This category enables foreign manufacturers to legally market their products in India through an authorized local representative.

The Authorized Indian Agent (AIA) plays a central role in the medical device import licensing process in India. The functions and responsibilities of AIA under the Medical Device Rules, 2017 are as follows:

• Filing of MD-14 Application: AIA is accountable for drafting and filing of the MD-14 form on the CDSCO SUGAM portal and for handling all proceedings until the issuance of Form MD-15.
• Maintenance of Technical Documentation: Authorized agent maintains the Plant Master File (PMF) and Device Master File (DMF) on behalf of the foreign manufacturer in accordance with the Medical Device Rules, 2017.
• Importer-of-Record: They act as the importer of record for customs clearance and takes legal liability for the imported shipments in India.
• Post-Market Surveillance: An Indian authorized agent is required to report adverse events and product complaints under the Materiovigilance Programme of India (MvPI), as administered by the Indian Pharmacopoeia Commission.
• License Retention and Updates: AIA ensures timely payment of the retention fee every five years and manages all endorsements, variations, and post-approval changes related to the MD-15 license.
• Regulatory Inspections: They coordinate and facilitate inspections of the foreign manufacturing site by CDSCO , wherever applicable.

CDSCO classifies medical devices into four risk classes based on intended use and risk profile. Classification is the single decision that determines fees, documents required, review timelines, and chances of an overseas inspection.

Not all medical devices imported in India need an MD-15 license. The type of license required depends on whether the medical device is notified or non-notified under the Medical Device Rules, 2017.

• Notified Medical Devices: All medical devices which are officially regulated by CDSCO, including Class A (sterile or measuring), Class B, Class C, and Class D are notified medical devices. These devices must have an MD-15 import license before they can be imported and sold in India.
• Non-Notified Medical Devices: These devices are medical devices that are not yet covered under the Medical Devices Rules, 2017. Non-notified medical devices do not require an MD-15 license before they are imported or sold in India.

In-Vitro Diagnostic (IVD) Devices and non-IVD medical devices require an MD-15 license before they are imported in India. The key differences between IVD & Non-IVD medical devices are given below:

• Non-IVD Medical Devices: Non-IVD Medical Devices include products such as syringes, implants, ventilators, and imaging equipment. These devices follow the standard MD-14 / MD-15 import licensing pathway under MDR 2017, with fees and documentation as prescribed in the Second and Fourth Schedules of the Rules.
• In-Vitro Diagnostic (IVD) Devices: In-Vitro Diagnostic (IVD) Devices include test kits, reagents, and laboratory diagnostic equipment such as blood glucose meters, HIV test kits, COVID-19 test kits, and pregnancy test kits. While IVDs are regulated under the same MD-14 / MD-15 framework, they are subject to a separate fee structure and may also require Performance Evaluation approval from CDSCO before the grant of the import license, depending on the type and risk class of the IVD.

After the issuance of an MD-15 import license, any modifications to the license should be processed through the appropriate regulatory pathway prescribed under the Medical Device Rules, 2017. Depending upon the type of change, the appropriate method could either be Endorsement, PAC, or even a New Application under MD-14. The details of each are explained below:

What if Your Medical Device has no Predicate Equivalent in India

Predicate devices are medical devices similar in terms of type, purpose, and technical that has already been approved by CDSCO and is currently available in the Indian market. Predicate devices play an important role in the import licensing process, as they help establish a regulatory benchmark for new devices entering the country.

If the medical device proposed to be imported in India does not have a predicate equivalent already approved in India, the applicant cannot directly Form MD-14 for an import license. In such cases, the foreign manufacturer must apply to the Central Licensing Authority (CLA) through the Authorized Indian Agent by filing Form MD-26. Upon successful review of the application, the CLA grants permission to import or manufacture the new medical device through Form MD-27.

Once the MD-27 permission is obtained, the applicant can then proceed to file the MD-14 application for the grant of the MD-15 import license under the standard procedure prescribed in the Medical Device Rules, 2017.

The key post-market compliance requirements applicable to MD-15 license holders are listed below:

• Adverse Event Reporting: All adverse events and product-related incidents must be reported to the Materiovigilance Programme of India (MvPI), which is regulated by the Indian Pharmacopoeia Commission (IPC).
• Maintenance of Distribution Records: Distribution records of all imported medical devices must be maintained for at least 5 years.
• Complaint Tracking and Investigation: All customer complaints related to the device must be tracked, investigated, and resolved through appropriate corrective action.
• Periodic Safety Update Reports (PSURs): PSURs must be submitted to CDSCO at the prescribed intervals based on the risk class of the device.

Several MD-14 applications are rejected or returned by CDSCO due to some easily preventable mistakes regarding classification, documentation, or procedural requirements. Early identification of such errors ensures smooth approval process. Most common reasons for rejection of MD-14 applications are listed below:

• Incorrect Device Classification: Inappropriate classification results in wrong fees, incorrect documentation, and review process.
• Incorrect Product Information: Discrepancy between the product name in the POA, FSC, label, and Instructions for Use also results in rejection during review.
• Invalid or Limited AIA Wholesale License: Application gets rejected if the Authorised Indian Agent's wholesale license is expired or does not cover the relevant device class.
• Gaps in PMF or DMF: Plant Master File or Device Master File not aligned with Appendix I or II of the Fourth Schedule of MDR 2017 leads to deficiency queries.